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IMPORTANT SAFETY INFORMATION FOR JEUVEAU® (prabotulinumtoxinA-xvfs)WARNING: DISTANT SPREAD OF TOXIN EFFECT: The effects of all botulinum toxin products, including JEUVEAU, may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. JEUVEAU is not approved for the treatment of spasticity or any conditions other than glabellar lines.CONTRAINDICATIONSJEUVEAU is contraindicated in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation, and in the presence of infection at the proposed injection site(s).WARNINGS AND PRECAUTIONSSpread of Toxin EffectPostmarketing safety data from other approved botulinum toxins suggest that botulinum toxin effects may be observed beyond the site of local injection. The symptoms are consistent with the mechanism of action of botulinum toxin and may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, blurred vision and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death related to spread of toxin effects. In unapproved uses, including upper limb spasticity in children and approved indications, symptoms consistent with spread of toxin effect have been reported at doses comparable to or lower than the maximum recommended total dose. JEUVEAU is not approved for the treatment of spasticity or any conditions other than glabellar lines. Patients or caregivers should be advised to seek immediate medical care if swallowing, speech or respiratory difficulties occur.Lack of Interchangeability between Botulinum Toxin ProductsThe potency Units of JEUVEAU are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of JEUVEAU cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay method.Serious Adverse Reactions with Unapproved UseSerious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received botulinum toxin injections for unapproved uses. In these cases, the adverse reactions were not necessarily related to distant spread of toxin, but may have resulted from the administration of botulinum toxin products to the site of injection and/or adjacent structures. In several of the cases, patients had pre-existing dysphagia or other significant disabilities. There is insufficient information to identify factors associated with an increased risk for adverse reactions associated with the unapproved uses of botulinum toxin products.Hypersensitivity ReactionsSerious and/or immediate hypersensitivity reactions have been reported for botulinum toxin products, including anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such reactions occur with JEUVEAU, discontinue use of JEUVEAU and immediately institute appropriate medical therapy.Cardiovascular SystemThere have been reports following administration of botulinum toxins of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including pre-existing cardiovascular disease. Use caution when administering to patients with pre-existing cardiovascular disease.Increased Risk of Clinically Significant Effects with Pre-existing Neuromuscular DisordersIndividuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junction disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) were excluded from the JEUVEAU clinical studies. Patients with neuromuscular disorders may be at increased risk of clinically significant effects, including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia and respiratory compromise from typical doses of JEUVEAU.Dysphagia and Breathing DifficultiesTreatment with botulinum toxin products, including JEUVEAU, can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing.Deaths as a complication of severe dysphagia have been reported after treatment with botulinum toxin. Dysphagia may persist for several months, and require use of a feeding tube to maintain adequate nutrition and hydration. Aspiration may result from severe dysphagia and is a particular risk when treating patients in whom swallowing or respiratory function is already compromised.Patients treated with botulinum toxin products, including JEUVEAU, may require immediate medical attention should they develop problems with swallowing, speech or breathing.Pre-existing Conditions at the Injection SiteCaution should be used when JEUVEAU is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s). Caution should be used when JEUVEAU treatment is used in patients who have marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin or when subjects do not respond to 20 Units of botulinum toxin (e.g. the inability to substantially lessen glabellar lines even by physically spreading them apart). Do not exceed the recommended dosage and frequency of administration of JEUVEAU.Ophthalmic Adverse Reactions in Patients Treated with Botulinum Toxin ProductsDry eye has been reported with the use of botulinum toxin products in the treatment of glabellar lines. Reduced tear production, reduced blinking, and corneal disorders, may occur with use of botulinum toxins, including JEUVEAU. If symptoms of dry eye (e.g., eye irritation, photophobia, or visual changes) persist, consider referring patient to an ophthalmologist.Human Albumin and Transmission of Viral DiseasesJEUVEAU contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) is also considered extremely remote. No cases of transmission of viral diseases or CJD have ever been reported for albumin.ADVERSE REACTIONSThe most frequently reported adverse reactions (≥ 1% and placebo) following injection of JEUVEAU were headache (12%), eyelid ptosis (2%), upper respiratory tract infection (3%), and white blood cell count increase (1%).DRUG INTERACTIONSNo formal drug interaction studies have been conducted with JEUVEAU. The potential for certain drugs to potentiate the effects of JEUVEAU warrant consideration given the potential risks involved and should be used with caution, including: aminoglycosides or other agents interfering with neuromuscular transmission, anticholinergic drugs, botulinum neurotoxin products, and muscle relaxants.USE IN SPECIFIC POPULATIONSThe limited available data on JEUVEAU use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes.There are no data on the presence of JEUVEAU in human or animal milk, its effects on the breastfed infant, or its effects on milk production.Safety and effectiveness in pediatric patients have not been established.INDICATIONJEUVEAU is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.Please note that this information is not comprehensive. For more information about JEUVEAU, see the full Prescribing Information including BOXED WARNING, and Medication Guide, visit evolus.com. To report side effects associated with use of JEUVEAU, please call 1-877-EVOLUS1/1-877-386-5871. You are encouraged to report side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.Exclusively licensed and manufactured for: Evolus, Inc., 520 Newport Center Drive, Suite 1200, Newport Beach, CA 92660©2020 Evolus, Inc. All rights reserved. All trademarks are the property of their respective owners.techniques to achieve outstanding results for our clients.
What is Revanesse® Versa™+?
Revanesse® Versa™+ is an FDA approved hyaluronic acid dermal filler that can be used to treat moderate to severe facial wrinkles and folds, including nasolabial folds in patients 22 years of age or older.
What is Revanesse® Lips™+?
Revanesse® Lips™+ is an FDA approved hyaluronic acid dermal filler that can be used for submucosal implantation for lip augmentation in patients 22 years of age or older.
Are there any reasons (contraindications) I should not receive a Revanesse® Versa™+ or Revanesse® Lips™+ injection?
You should not be treated if you:
If you are under the age of 22 you should not be treated with a Revanesse® dermal filler.
It’s not recommended to use Revanesse® dermal fillers in conjunction with a laser, intense pulsed light, chemical peeling or dermabrasion treatments, or with Over-the-counter (OTC) wrinkle products or prescription wrinkle treatments within 4 weeks prior to treatment, as there is a possible risk of inflammation or infection at the treatment site.
What are the risks?The most common reported side effects are bleeding, bruising, swelling, and pain.
Other risks that are less likely, but may occur, include: Acne-like skin eruptions, skin sensitivity (rash, itching, tenderness), skin infection, damage to nerves or blood vessels, skin lumpiness, scarring, skin necrosis, hyperpigmentation, reactivation of herpes infection (blisters or skin sores).
If you have an adverse reaction or side effect that persists for one week or more after treatment with a Revanesse® dermal filler, please contact your healthcare provider.
Warning: One of the risks of being injected with any dermal filler is unintentional injection into a blood vessel. These complications, which have been reported with facial injectable fillers, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin.
Patient Assistance Information:If you require immediate medical assistance, please contact your health care provider. For further assistance, please contact Prollenium Medical Technologies Inc. at 1-866-353-3017 (24 hours a day).
For more information about Revanesse® Versa™ or Revanesse® Lips™, please see their Directions for Use or speak to your health care provider.
